The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended the approval of Proveca’s Sialanar (glycopyrronium bromide) for the treatment of severe drooling in children and adolescents with neurological disorders, such as cerebral palsy.
Children with cerebral palsy and other motor or neurological disorders are often unable to effectively swallow the saliva produced, leading to unavoidable chronic drooling and significant negative impact in the child’s wellbeing and quality of life.
The EMA’s decision came out of a CHMP meeting in July to discuss potential approval of new medications. It followed a previous negative opinion by CHMP in April when the committee expressed concern about the lack of adequate safety data in patients with neurological conditions —nand did not find proof that Sialanar improved patients’ quality of life.
Proveca followed up the April decision with a request for the drug to be re-evaluated, presenting data from two published studies comparing the drug with placebo in 77 children with neurological conditions and severe drooling.
During the re-examination, CHMP consulted experts in the field, who recommended Sialanar for the short-term treatment of severe drooling in children and adolescents. As is stated in a report, the committee agreed with the experts that benefits of the treatment outweighed the risks, and recommended granting Sialanar a pediatric use marketing authorization (PUMA). PUMAs are restricted to drugs already on the market and approved for children, but no longer under patent protection. Sialanar is only the third drug to be recommended for a PUMA since this type of authorization was introduced in 2007.
Within the E.U., the actual approval of drugs is done by the European Commission following recommendations from EMA’s CHMP. Once approved, the drug will be available as an oral solution. The medicine acts on muscarinic receptors in the body that lower the production of saliva. Side effects of the drug are mainly tied to its working mechanism which might also lead to constipation, diarrhea, vomiting, urinary retention, and nasal congestion.
In the EMA’s official “summary of opinion,” the committee wrote that should be “prescribed by physicians experienced in the treatment of pediatric patients with neurological disorders. Due to limited long-term safety data, the treatment duration should be kept as short as possible and closely monitored.”
Proveca is a firm specializing in re-engineering generic drugs mostly for chronic conditions, for safe and suitable use by children and adolescents.